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OpenTrials
Completed

NCT Number: NCT01862861

Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, 32216, United States

About this study

Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
  • Participants must be starting a new regimen of bioidentical hormone replacement therapy.
  • Participants must be expected to receive therapy for at least 12 weeks.
  • Participants must be between 30 and 65 years of age.
  • Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion criteria

  • Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
  • Participants must not be pregnant or breastfeeding women.
  • Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
  • Participants must not be using another bioidentical hormone at the time of enrollment.

Treatment and study plan

Primary outcomes

  1. To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.

    Time frame: 12 Week Study

    The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks.

Secondary outcomes

  1. To evaluate health-related quality of life (HrQol)

    Time frame: 12 Weeks

    The quality of life (HrQol) will be evaluated by utilizing the Women's Health Questionnaire (WHQ)at baseline and at end of study at 12 weeks.

Sponsors and collaborators

Lead sponsor

Medimix Specialty Pharmacy, LLC

Industry

Registry information

Acronym: REVERT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 27, 2013
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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